FDA Urged to Ban Cephalosporin Use in Food Animals

Jul 28, 2011   

In July 2008, the FDA announced it would implement a rule to prohibit the extra-label use of cephalosporins but then revoked the order to consider all comments received on the prohibition. On July 21, 2011, U.S. House Representative Louise Slaughter (D-NY) urged U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg to finalize a stalled rule to ban extra-label use of the cephalosporin class of antibiotics in food-producing animals.

Cephalosporins are primarily used on poultry, cattle and pork farms, where the FDA has approved their use for numerous veterinary purposes. However, farmers have also adopted “extra-label” or preventative uses of cephalosporin. In one such use, shells of chicken eggs are pierced just before hatching and injected with doses of third-generation cephalosporin antibiotics, ceftiofur, in order to suppress infection outbreaks. Cephalosporins are also used to treat baterical infections in humans.

Advocates for the ban insist that the extra-label use of cephalosporins in food-producing animals is likely to lead to the emergence of cephalosporin-resistant strains of foodborne bacterial pathogens. If these drug-resistant bacterial strains infect humans, it is likely that cephalosporins will no longer be an effective treatment. Currently, human drug-resistant bacteria strains include E. coli, salmonella, and gonorrhea.

Groups, such as the American Veterinary Medical Association (AVMA), protested the 2008 prohibition of extra-label use of cephalosporin. The AVMA insists that studies cited by the FDA fail to directly demonstrate that veterinary use of cephalosporins impairs human medicine. Additionally, the FDA prohibition would put animals at risk because extra-label cephalosporin use is medically necessary to relieve animal pain and suffering. Just weeks after the AVMA filed its protest, the FDA reversed the prohibition.

Congresswoman Slaughter also authored legislation to amend the Federal Food, Drug, and Cosmetic Act (FD&C Act) to preserve the effectiveness of medically important antibiotics used in the treatment of human and animal diseases. The House Bill, known as the Preservation of Antibiotics for Medical Treatment Act of 2011, would require the Secretary of Health and Human Services (HHS) to deny applications and withdraw approval of nontherapeutic uses of antibiotics in food-producing animals that are also used in humans to treat or prevent disease. Currently, there is a similar Senate version of the House Bill in committee.

Fuerst Ittleman will continue to monitor the progress of the FDAs regulation of antibiotics in food animals. For more information, please contact us at contact@fidjlaw.com.